- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00974727
A Gardening Program to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children
October 1, 2015 updated by: University of Wisconsin, Madison
Use of Biomarkers to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children
The purpose of this study is to examine the impact of a summer gardening program on summer weight gain in overweight middle school children.
Study Overview
Detailed Description
In the past two decades, the combination of unhealthy eating and physical inactivity has contributed to doubling the percentage of children and adolescents who are overweight.
Childhood overweight is known to lead to increased risk for several morbidities in childhood and into adulthood including type 2 diabetes mellitus, hypertension, and cardiovascular disease.
Recent data shows that children experience greater and more variable increases in BMI during summer vacation than during the school year.
Our project aims to determine whether summer weight gain is due to a decrease in physical activity or an increase in daily calories as well as to assess the effectiveness of a summer gardening program on preventing summer body fat gain.
We will randomize 40 middle-school children who are above the 95th percentile for BMI into either a control or intervention group.
The control group will receive the standard of care and the intervention group will participate in Garden Fit, a summer gardening project at Troy Gardens in Madison, WI.
As part of Garden Fit, subjects will participate in weeding, landscaping and trail maintenance activities as well as preparing meals twice a week with fresh foods from the gardens.
We hypothesize that summer weight gain is due to a worsening of healthy lifestyle (decreased physical activity from school to summer and increased eating of high calorie snacks).
Additionally, we hypothesize that an intervention that increases physical activity and provides increased access to healthy foods will reduce the trend of summer BMI increase.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53706
- University of Wisconsin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Middle school child aged 10-14 years
- BMI at or above the 85th percentile for height and weight
- Able to attend 8-week summer program and clinic visits
Exclusion Criteria:
- Any known metabolic disorder
- Any physical disability that prevents or limits physical activity
- Claustrophobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gardening Program
|
8-week summer gardening program.
9am-12pm on Monday, Wednesday, Friday and 9am-12:30pm on Tuesday and Thursday.
Activities included gardening (preparing soil for planting, planting seeds and seedlings, mulching, weeding, watering, and harvesting), preparing meals with fresh foods from the garden, and other garden activities and games.
Other Names:
|
No Intervention: Control
Subjects received the standard of care for the summer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BMI
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fitness (as measured by VO2 Submax testing)
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Resting Metabolic Rate
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Fasting insulin
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Fasting glucose
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
CRP
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
IL-6
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Body Composition
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Plasma Carotenoids
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Total Energy Expenditure
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Food Consumption (measured by FFQs)
Time Frame: June 2009 and August 2009
|
June 2009 and August 2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dale Schoeller, Ph.D., University of Wisconsin, Department of Nutritional Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.
- Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
- Ferraro KF, Thorpe RJ Jr, Wilkinson JA. The life course of severe obesity: does childhood overweight matter? J Gerontol B Psychol Sci Soc Sci. 2003 Mar;58(2):S110-9. doi: 10.1093/geronb/58.2.s110.
- Carrel AL, Clark RR, Peterson S, Eickhoff J, Allen DB. School-based fitness changes are lost during the summer vacation. Arch Pediatr Adolesc Med. 2007 Jun;161(6):561-4. doi: 10.1001/archpedi.161.6.561.
- Gillis L, McDowell M, Bar-Or O. Relationship between summer vacation weight gain and lack of success in a pediatric weight control program. Eat Behav. 2005 Feb;6(2):137-43. doi: 10.1016/j.eatbeh.2004.08.002.
- von Hippel PT, Powell B, Downey DB, Rowland NJ. The effect of school on overweight in childhood: gain in body mass index during the school year and during summer vacation. Am J Public Health. 2007 Apr;97(4):696-702. doi: 10.2105/AJPH.2005.080754. Epub 2007 Feb 28.
- Hull HR, Morrow ML, Heesch KC, Dinger MK, Han JL, Fields DA. Effect of the summer months on body weight and composition in college women. J Womens Health (Larchmt). 2007 Dec;16(10):1510-5. doi: 10.1089/jwh.2006.0329.
- Gutin B. Child obesity can be reduced with vigorous activity rather than restriction of energy intake. Obesity (Silver Spring). 2008 Oct;16(10):2193-6. doi: 10.1038/oby.2008.348. No abstract available.
- Gutin B, Barbeau P, Owens S, Lemmon CR, Bauman M, Allison J, Kang HS, Litaker MS. Effects of exercise intensity on cardiovascular fitness, total body composition, and visceral adiposity of obese adolescents. Am J Clin Nutr. 2002 May;75(5):818-26. doi: 10.1093/ajcn/75.5.818.
- Johnson L, Mander AP, Jones LR, Emmett PM, Jebb SA. Energy-dense, low-fiber, high-fat dietary pattern is associated with increased fatness in childhood. Am J Clin Nutr. 2008 Apr;87(4):846-54. doi: 10.1093/ajcn/87.4.846.
- Wang YC, Bleich SN, Gortmaker SL. Increasing caloric contribution from sugar-sweetened beverages and 100% fruit juices among US children and adolescents, 1988-2004. Pediatrics. 2008 Jun;121(6):e1604-14. doi: 10.1542/peds.2007-2834.
- Carrel AL, Clark RR, Peterson SE, Nemeth BA, Sullivan J, Allen DB. Improvement of fitness, body composition, and insulin sensitivity in overweight children in a school-based exercise program: a randomized, controlled study. Arch Pediatr Adolesc Med. 2005 Oct;159(10):963-8. doi: 10.1001/archpedi.159.10.963.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
September 9, 2009
First Submitted That Met QC Criteria
September 9, 2009
First Posted (Estimate)
September 10, 2009
Study Record Updates
Last Update Posted (Estimate)
October 5, 2015
Last Update Submitted That Met QC Criteria
October 1, 2015
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSN106189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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